NCT00694577已完成不适用
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 8
- 主要终点
- Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.
研究概览
简要总结
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
详细描述
- In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation".
- Participants will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments.
- Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy.
- We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial.
- Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
- •Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT
- •18 years of age or older
- •ECOG Performance Status 0
- •Required laboratory data as outlined in the protocol
排除标准
- •Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
- •Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
- •Tumor > 2.0cm, nodal involvement, or metastatic involvement
- •Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma
- •Known mutation carrier, including BRCA1 and BRCA2
- •History of cosmetic or reconstructive breast surgery
- •Psychiatric illness which would prevent the patient from giving informed consent
- •Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease
- •Participants with a "currently active" second malignancy other than non-melanoma skin cancers
- •Patients with diffuse (> 1 quadrant or >5cm) suspicious microcalcifications
- •Women who are pregnant
结局指标
主要结局
Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.
时间窗: 10 years
Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility.
Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy
时间窗: 10 years
Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy
次要结局
- To Evaluate Patient Satisfaction(8 years)
- Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint(8 years)
- Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation(8 years)
- Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation(8 years)
研究者
Alphonse Taghian, MD, PhD
Professor of Radiation Oncology, Harvard Medical School
Massachusetts General Hospital
研究点 (8)
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